Annuloplasty ring with intra-ring anchoring

ABSTRACT

Apparatus is provided that includes an annuloplasty system for use on a subject. The system includes an annuloplasty ring, which includes a sleeve having a lumen, and at least one anchor, shaped so as to define a coupling head and a tissue coupling element, which tissue coupling element is shaped so as to define a longitudinal axis, and is configured to penetrate cardiac tissue of the subject in a direction parallel to the longitudinal axis. The system further includes an anchor deployment manipulator, configured to be removably positioned within the lumen of the sleeve, and, while so positioned, to deploy the tissue coupling element from a distal end of the deployment manipulator through a wall of the sleeve into the cardiac tissue in the direction parallel to the longitudinal axis of the tissue coupling element and parallel to a central longitudinal axis through the distal end of the deployment manipulator.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.12/437,103, filed May 7, 2009.

FIELD OF THE INVENTION

The present invention relates in general to valve repair, and morespecifically to repair of an atrioventricular valve of a patient.

BACKGROUND OF THE INVENTION

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

US Patent Application Publication 2007/0055206 to To et al., which isincorporated herein by reference, describes devices, methods, and kitsfor deployment of tissue anchors. In some variations, the devicescomprise a shaft defining a lumen for housing at least one anchortherein (the anchor having an eyelet) and a mechanism for deploying theanchor distally from the lumen, wherein the inner diameter of the lumenis the same size or smaller than the diameter of the eyelet of theanchor to be disposed therein when the anchor is in an expandedconfiguration. In some variations, the methods comprise loading ananchor within a lumen of a shaft (where the anchor comprises an eyeletand the shaft has a slot therethrough), passing a linking member throughthe slot and through the eyelet of the anchor, and deploying the anchor.Other methods comprise loading an anchor within a lumen of a shaft, anddeploying the anchor distally from the lumen.

US Patent Application Publication 2007/0080188 to Spence et al., whichis incorporated herein by reference, describes systems and methods forsecuring tissue including the annulus of a mitral valve. The systems andmethods may employ catheter based techniques and devices 15 to plicatetissue and perform an annuloplasty. Magnets may be used for guidance indeploying fasteners from a catheter. The fasteners are cinched with aflexible tensile member.

U.S. Pat. No. 6,619,291 to Hlavka et al., which is incorporated hereinby reference, describes a minimally invasive method of performingannuloplasty. A method for performing a procedure on a mitral valve of aheart includes inserting an implant into a left ventricle and orientingthe implant in the left ventricle substantially 25 below the mitralvalve. The implant and tissue around the mitral valve are connected andtension is provided to the implant, in one embodiment, in order tosubstantially reduce an arc length associated with the mitral valve. Inanother embodiment, the implant is inserted into the 30 left ventriclethrough the aorta and the aortic valve.

US Patent Application Publication 2006/0241656 to Starksen et al., whichis incorporated herein by reference, describes devices, systems andmethods for facilitating positioning of a cardiac valve annulustreatment device, thus enhancing treatment of the annulus. Methodsgenerally involve advancing an anchor delivery device throughvasculature of the patient to a location in the heart for treating thevalve annulus, contacting the anchor delivery device with a length ofthe valve annulus, delivering a plurality of coupled anchors from theanchor delivery device to secure the anchors to the annulus, and drawingthe anchors together to circumferentially tighten the valve annulus.Devices generally include an elongate catheter having at least onetensioning member and at least one tensioning actuator for deforming adistal portion of the catheter to help it conform to a valve annulus.The catheter device may be used to navigate a subannular space below amitral valve to facilitate positioning of an anchor delivery device.

US Patent Application Publication 2007/0051377 to Douk et al., which isincorporated herein by reference, describes a catheter-based, annulusreduction device and system for cardiac valve repair and method of usingthe same. The system is usable for treating mitral valve regurgitationand comprises a catheter, a reduction ring carried within the catheter,the reduction ring including a plurality of exit ports formed in a sidewall of the reduction ring and filament received in the reduction ring.The filament includes a plurality of radially extendible barbscorresponding to the sidewall openings. The reduction ring carrying thefilament is deployed adjacent a mitral valve annulus and the filament istranslated relative to the reduction ring to deploy the barbs throughthe exit ports and into the annulus and to further translate thereduction ring with deployed barbs to reshape the annulus.

US Patent Application Publication 2006/0025787 to Morales et al., whichis incorporated herein by reference, describes methods and devices thatprovide constriction of a heart valve annulus to treat cardiac valveregurgitation and other conditions. Embodiments typically include adevice for attaching a cinching or tightening apparatus to a heart valveannulus to reduce the circumference of the annulus, thus reducing valveregurgitation. Tightening devices may include multiple tethered clips,multiple untethered crimping clips, stabilizing devices, visualizationdevices, and the like. In one embodiment, a plurality of tethered clipsis secured circumferentially to a valve annulus, and the tether couplingthe clips is cinched to reduce the circumference of at least a portionof the annulus. Methods and devices may be used in open heart surgicalprocedures, minimally invasive procedures, catheter-based procedures,and/or procedures on beating hearts or stopped hearts.

U.S. Pat. No. 7,431,692 to Zollinger et al., which is incorporatedherein by reference, describes an adjustable support pad for adjustablyholding a tensioning line used to apply tension to a body organ. Theadjustable support pad can include a locking mechanism for preventingslidable movement of the tensioning element in one or both directions.The locking mechanism may include spring-loaded locks, rotatablecam-like structures, and/or rotatable spool structures. The adjustablesupport pad may be formed from rigid, semi-rigid, and/or flexiblematerials, and may be formed to conform to the outer surface of a bodyorgan. The adjustable support pad can be configured to adjustably holdone or more separate tensioning lines, and to provide for independentadjustment of one or more tensioning lines or groups thereof.

US Patent Application Publication 2007/0016287 to Cartledge et al.,which is incorporated herein by reference, describes an implantabledevice for controlling shape and/or size of an anatomical structure orlumen. The implantable device has an adjustable member configured toadjust the dimensions of the implantable device. The implantable deviceis housed in a catheter and insertable from a minimally invasivesurgical entry. An adjustment tool actuates the adjustable member andprovide for adjustment before, during or after the anatomical structureor lumen resumes near normal to normal physiologic function.

US Patent Application Publication 2004/0236419 to Milo, which isincorporated herein by reference, describes methods for reconfiguring anatrioventricular heart valve that may use systems comprising a partialor complete annuloplasty rings proportioned to reconfigure a heart valvethat has become in some way incompetent, a pair of trigonal sutures orimplantable anchors, and a plurality of staples which may have pairs oflegs that are sized and shaped for association with the ring at spacedlocations along its length. These systems permit relative axial movementbetween the staples and the ring, whereby a patient's heart valve can bereconfigured in a manner that does not deter subtle shifting of thenative valve components. Shape-memory alloy material staples may havelegs with free ends that interlock following implantation. Annuloplastyrings may be complete or partial and may be fenestrated. One alternativemethod routes a flexible wire, preferably of shape-memory material,through the bights of pre-implanted staples. Other alternative systemsuse linkers of shape-memory material having hooked ends to interengagewith staples or other implanted supports which, following implantation,decrease in effective length and pull the staples or other supportstoward one another so as to create desired curvature of the reconfiguredvalve. These linkers may be separate from the supports or may beintegral with them and may have a variety of shapes and forms. Variousones of these systems are described as being implanted non-invasivelyusing a delivery catheter.

US Patent Application Publication 2005/0171601 to Cosgrove et al., whichis incorporated herein by reference, describes an annuloplasty repairsegment and template for heart valve annulus repair. The elongateflexible template may form a distal part of a holder that also has aproximal handle. Alternatively, the template may be releasably attachedto a mandrel that slides within a delivery sheath, the template beingreleased from the end of the sheath to enable manipulation by a surgeon.A tether connecting the template and mandrel may also be provided. Thetemplate may be elastic, temperature responsive, or multiple linkedsegments. The template may be aligned with the handle and form a two- orthree-dimensional curve out of alignment with the handle such that theannuloplasty repair segment attached thereto conforms to the curve. Thetemplate may be actively or passively converted between its straight andcurved positions. The combined holder and ring is especially suited forminimally-invasive surgeries in which the combination is delivered to animplantation site through a small access incision with or without acannula, or through a catheter passed though the patient's vasculature.

The following patents and patent application publications, all of whichare incorporated herein by reference, may be of interest:

-   U.S. Pat. No. 5,306,296 to Wright et al.-   U.S. Pat. No. 5,674,279 to Wright et al.-   U.S. Pat. No. 5,961,539 to Northrup, III et al.-   U.S. Pat. No. 6,524,338 to Gundry-   U.S. Pat. No. 6,569,198 to Wilson et al.-   U.S. Pat. No. 6,602,288 to Cosgrove et al.-   U.S. Pat. No. 6,602,289 to Colvin et al.-   U.S. Pat. No. 6,689,164 to Seguin-   U.S. Pat. No. 6,702,826 to Liddicoat et al.-   U.S. Pat. No. 6,718,985 to Hlavka et al.-   U.S. Pat. No. 6,764,510 to Vidlund et al.-   U.S. Pat. No. 7,004,176 to Lau-   U.S. Pat. No. 7,101,395 to Tremulis et al.-   U.S. Pat. No. 7,175,660 to Cartledge et al.-   U.S. Pat. No. 7,186,262 to Saadat-   US Patent Application Publication 2002/0087048 to Brock et al.-   US Patent Application Publication 2002/0173841 to Ortiz et al.-   US Patent Application Publication 2003/0050693 to Quijano et al.-   US Patent Application Publication 2003/0167062 to Gambale et al.-   US Patent Application Publication 2004/0024451 to Johnson et al.-   US Patent Application Publication 2004/0148021 to Cartledge et al.-   US Patent Application Publication 2005/0055087 to Starksen-   US Patent Application Publication 2005/0288781 to Moaddeb et al.-   US Patent Application Publication 2006/0069429 to Spence et al.-   PCT Publication WO 01/26586 to Seguin-   PCT Publication WO 02/085251 to Hlavka et al.-   PCT Publication WO 02/085252 to Hlavka et al.-   PCT Publication WO 07/136,783 to Cartledge et al.

The following articles, all of which are incorporated herein byreference, may be of interest:

-   O'Reilly S et al., “Heart valve surgery pushes the envelope,”    Medtech Insight 8(3): 73, 99-108 (2006)-   Dieter R S, “Percutaneous valve repair: Update on mitral    regurgitation and endovascular approaches to the mitral valve,”    Applications in Imaging, Cardiac Interventions, Supported by an    educational grant from Amersham Health pp. 11-14 (2003)-   Swain C P et al., “An endoscopically deliverable tissue-transfixing    device for securing biosensors in the 25 gastrointestinal tract,”    Gastrointestinal Endoscopy 40(6): 730-734 (1994)-   Odell J A et al., “Early Results of a Simplified Method of Mitral    Valve Annuloplasty,” Circulation 92:150-154 (1995)

SUMMARY OF THE INVENTION

In some embodiments of the present invention, an adjustable partialannuloplasty ring is provided for repairing a dilated valve annulus ofan atrioventricular valve, such as a mitral valve. The annuloplasty ringcomprises a flexible sleeve and a plurality of anchors. An anchordeployment manipulator is advanced into a lumen of the sleeve, and, fromwithin the lumen, deploys the anchors through a wall of the sleeve andinto cardiac tissue, thereby anchoring the sleeve around a portion ofthe valve annulus. The anchors are typically deployed from a distal endof the manipulator while the distal end is positioned such that acentral longitudinal axis through the distal end of the manipulatorforms an angle with a surface of the cardiac tissue of between about 45and 90 degrees, e.g., between about 75 and 90 degrees, such as about 90degrees. Typically, the anchors are deployed from the distal end of themanipulator into the cardiac tissue in a direction parallel to thecentral longitudinal axis through the distal end of the manipulator.

In some embodiments of the present invention, the anchors are deployedfrom the left atrium into the upper region of the ventricular wall nearthe atrium, tissue of which generally provides more secure anchoringthan does the atrial wall. The above-mentioned angle of deploymentenables such deployment into the upper region of the ventricular wall.

In some embodiments of the present invention, the anchor deploymentmanipulator comprises a steerable outer tube in which is positioned ananchor driver having an elongated, flexible shaft. Rotation of theanchor driver screws the anchors into the cardiac tissue. The anchorsmay, for example, be helical in shape. For some applications, theplurality of anchors are applied using the manipulator by loading afirst one of the anchors onto the anchor driver, and deploying theanchor into the cardiac tissue. The anchor driver is withdrawn from thebody of the subject, and a second one of the anchors is loaded onto theanchor driver. The anchor driver is reintroduced into the sleeve of theannuloplasty ring, and the second anchor is deployed. These steps arerepeated until all of the anchors have been deployed. Alternatively, theanchor driver is configured to simultaneously hold a plurality ofanchors, and to deploy them one at a time.

Typically, the manipulator is gradually withdrawn in a proximaldirection during the anchoring procedure as anchors are deployed. Thefirst anchor is thus deployed most distally in the sleeve (generally ator within a few millimeters of the distal tip of the sleeve), and eachsubsequent anchor is deployed more proximally.

The annuloplasty ring is typically configured to be placed onlypartially around the valve annulus (i.e., to assume a C-shape), and,once anchored in place, to be contracted so as to circumferentiallytighten the valve annulus. To this end, the annuloplasty ring comprisesa flexible contracting member such as a wire, which is typicallypositioned within the lumen of the sleeve. The annuloplasty ring furthercomprises a contracting mechanism which facilitates contracting of theannuloplasty ring. For some applications, the contracting mechanismcomprises a spool to which a first end of the contracting member iscoupled. The spool is positioned in a vicinity of either the proximal orthe distal end of the sleeve. A second end of the contracting member iscoupled to the sleeve in a vicinity of the end of the sleeve oppositethe end to which the spool is positioned. Rotation of the spool winds aportion of the contracting member around the spool, thereby pulling thefar end of the ring toward the spool and tightening the ring. For someapplications, the spool is positioned in a vicinity of the distal end ofthe sleeve, and is oriented such that a driving interface thereof isaccessible from within the sleeve. A screwdriver tool is inserted intothe sleeve, and used to rotate the spool via the driving interface ofthe spool.

All of the tools and elements of the annuloplasty system that areintroduced into left atrium are contained within the sleeve of theannuloplasty ring, which reduces the risk that any elements of thesystem will accidentally be released to the blood circulation, or damagesurrounding tissue. In addition, the lumen of the sleeve providesguidance if it should be necessary to return to a previously deployedanchor, such as to tighten, loosen, remove, or relocate the anchor. Forsome applications, the anchors comprise helical screws, which facilitatesuch adjusting or removing.

The annuloplasty ring may be advanced toward the annulus of a valve inany suitable procedure, e.g., a transcatheter procedure, a minimallyinvasive procedure, or an open heart procedure.

There is therefore provided, in accordance with an embodiment of thepresent invention, apparatus including an annuloplasty system for use ona subject, which includes:

an annuloplasty ring, which includes a sleeve having a lumen;

at least one anchor, shaped so as to define a coupling head and a tissuecoupling element, which tissue coupling element is shaped so as todefine a longitudinal axis, and is configured to penetrate cardiactissue of the subject in a direction parallel to the longitudinal axis;and

an anchor deployment manipulator, configured to be removably positionedwithin the lumen of the sleeve, and, while so positioned, to deploy thetissue coupling element from a distal end of the deployment manipulatorthrough a wall of the sleeve into the cardiac tissue in the directionparallel to the longitudinal axis of the tissue coupling element andparallel to a central longitudinal axis of the deployment manipulatorthrough the distal end of the deployment manipulator.

Typically, the annuloplasty ring includes a partial annuloplasty ring.

For some applications, the coupling element is shaped so as to define ashape selected from the group consisting of: a helix, a spiral, and ascrew shaft.

In an embodiment, the annuloplasty ring includes a spool coupled to thesleeve, and a flexible contracting member that is coupled to the spooland the sleeve, such that winding the contracting member around thespool tightens the ring.

In an embodiment, the deployment manipulator includes steeringfunctionality. For some applications, the deployment manipulatorincludes a tube, which is configured to provide the steeringfunctionality; and an anchor driver, which includes an elongated,flexible shaft which is at least partially positioned within the tube.

In an embodiment, the deployment manipulator is configured to deploy theat least one anchor from the distal end of the deployment manipulatorthrough the wall of the sleeve into the cardiac tissue, while the distalend of the deployment manipulator is positioned such that the centrallongitudinal axis through the distal end of the deployment manipulatorforms an angle of between 45 and 90 degrees with the wall of the sleeveat a point at which the anchor penetrates the wall. For someapplications, the point on the wall is a first point on the wall, andthe angle is a first angle, the at least one anchor is a first anchor ofa plurality of anchors that also includes a second anchor most recentlydeployed before the first anchor through a second point on the wall, andthe deployment manipulator is configured to deploy the first anchorwhile the distal end of the deployment manipulator is positioned suchthat the central longitudinal axis forms a second angle of between 45and 90 degrees with a line defined by the first point and the secondpoint.

For some applications, the apparatus further includes a pusher elementwhich is positioned within the sleeve, and which is configured to, uponbeing pushed distally, move the distal end of the deployment manipulatorproximally within the sleeve by engaging an interior surface of thesleeve.

There is further provided, in accordance with an embodiment of thepresent invention, a method including:

positioning an anchor deployment manipulator at least partially within alumen of a sleeve of an annuloplasty ring;

placing, into an atrium of a subject in a vicinity of an annulus of anatrioventricular valve, at least a portion of the sleeve that contains adistal end of the deployment manipulator; and

deploying at least one anchor from the distal end of the deploymentmanipulator through a wall of the sleeve such that a coupling element ofthe anchor enters cardiac tissue of the subject in a direction parallelto a central longitudinal axis of the deployment manipulator through thedistal end of the deployment manipulator.

In an embodiment, deploying includes deploying the at least one anchorfrom the distal end of the deployment manipulator through the wall ofthe sleeve into the cardiac tissue, while the distal end of thedeployment manipulator is positioned such that the central longitudinalaxis of the deployment manipulator through the distal end of thedeployment manipulator forms an angle of between 45 and 90 degrees withthe wall of the sleeve at a point at which the anchor penetrates thewall. For some applications, the point on the wall is a first point onthe wall, and the angle is a first angle, the at least one anchor is afirst anchor of a plurality of anchors that also includes a secondanchor most recently deployed before the first anchor through a secondpoint on the wall, and deploying the first anchor includes deploying thefirst anchor while the distal end of the deployment manipulator ispositioned such that the central longitudinal axis forms a second angleof between 45 and 90 degrees with a line defined by the first point andthe second point.

Typically, the annuloplasty ring includes a partial annuloplasty ring,and positioning the deployment manipulator includes positioning thedeployment manipulator within the lumen of the partial annuloplastyring.

In an embodiment, the deployment manipulator includes steeringfunctionality, and placing the sleeve includes steering the deploymentmanipulator using the steering functionality.

For some applications, deploying the anchor includes deploying theanchor from the atrium into an upper region of a ventricular wall nearthe atrium.

For some applications, the method further includes positioning a pusherelement at least partially within the lumen of the sleeve of theannuloplasty ring; and moving the distal end of the deploymentmanipulator proximally within the sleeve by pushing the pusher elementdistally such that the pusher element engages an interior surface of thesleeve.

In an embodiment, the method further includes tightening theannuloplasty ring by winding a flexible contracting member of the ringaround a spool coupled to the ring.

There is still further provided, in accordance with an embodiment of thepresent invention, apparatus including an annuloplasty system for use ona subject, which includes:

an annuloplasty ring, which includes a sleeve having a lumen;

at least one anchor; and

an anchor deployment manipulator, configured to be removably positionedwithin the lumen of the sleeve, and, while so positioned, to deploy theat least one anchor from a distal end of the deployment manipulatorthrough a wall of the sleeve into cardiac tissue of the subject, whilethe distal end of the deployment manipulator is positioned such that acentral longitudinal axis of the deployment manipulator through thedistal end of the deployment manipulator forms an angle of between 45and degrees with the wall of the sleeve at a point at which the anchorpenetrates the wall.

Typically, the annuloplasty ring includes a partial annuloplasty ring.

In an embodiment, the deployment manipulator includes steeringfunctionality.

For some applications, the point on the wall is a first point on thewall, and the angle is a first angle, the at least one anchor is a firstanchor of a plurality of anchors that also includes a second anchor mostrecently deployed before the first anchor through a second point on thewall, and the anchor deployment manipulator is configured to deploy thefirst anchor while the distal end of the deployment manipulator ispositioned such that the central longitudinal axis forms a second angleof between 45 and 90 degrees with a line defined by the first point andthe second point.

For some applications, the anchor is shaped so as to define a couplinghead and a tissue coupling element, which tissue coupling element isshaped so as to define a longitudinal axis, and is configured topenetrate cardiac tissue of the subject in a direction parallel to thelongitudinal axis, and the anchor deployment manipulator is configuredto deploy the anchor from the distal end of the deployment manipulatorsuch that the coupling element enters the cardiac tissue in a directionparallel to the central longitudinal axis of the deployment manipulatorthrough the distal end of the deployment manipulator.

For some applications, the anchor is shaped so as to define a couplinghead and a tissue coupling element, which is shaped so as to define ashape selected from the group consisting of: a helix, a spiral, and ascrew shaft.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method including:

positioning an anchor deployment manipulator at least partially within alumen of a sleeve of an annuloplasty ring;

placing, into an atrium of a subject in a vicinity of an annulus of anatrioventricular valve, at least a portion of the sleeve that contains adistal end of the deployment manipulator; and

deploying at least one anchor from the distal end of the deploymentmanipulator through a wall of the sleeve into cardiac tissue of thesubject, while the distal end of the deployment manipulator ispositioned such that a central longitudinal axis of the deploymentmanipulator through the distal end of the deployment manipulator formsan angle of between 45 and 90 degrees with the wall of the sleeve at apoint at which the anchor penetrates the wall.

For some applications, deploying includes deploying the at least oneanchor while the angle is between 75 and 90 degrees.

In an embodiment, the deployment manipulator includes steeringfunctionality, and placing the sleeve includes steering the deploymentmanipulator using the steering functionality.

Typically, the annuloplasty ring includes a partial annuloplasty ring,and positioning the anchor deployment manipulator includes positioningthe anchor deployment manipulator at least partially within the lumen ofthe partial annuloplasty ring.

For some applications, the point on the wall is a first point on thewall, and the angle is a first angle, the at least one anchor is a firstanchor of a plurality of anchors that also includes a second anchor mostrecently deployed before the first anchor through a second point on thewall, and deploying the first anchor includes deploying the first anchorwhile the distal end of the deployment manipulator is positioned suchthat the central longitudinal axis forms a second angle of between 45and 90 degrees with a line defined by the first point and the secondpoint.

For some applications, deploying the anchor includes deploying theanchor from the distal end of the deployment manipulator such that acoupling element of the anchor enters the cardiac tissue in a directionparallel to the central longitudinal axis.

For some applications, the anchor is shaped so as to define a couplinghead and a tissue coupling element, which is shaped so as to define ashape selected from the group consisting of: a helix, a spiral, and ascrew shaft, and deploying the anchor includes screwing the tissuecoupling element into the cardiac tissue.

In an embodiment, the method further includes tightening theannuloplasty ring by winding a flexible contracting member of the ringaround a spool coupled to the ring.

For some applications, deploying the anchor includes deploying theanchor from the atrium into an upper region of a ventricular wall nearthe atrium.

For some applications, the deployment manipulator includes an anchordriver positioned within a sheath, the at least one anchor includes aplurality of anchors, and deploying the at least one anchor includes:

-   -   loading a first one of the anchors onto the anchor driver;    -   deploying the first one of the anchors through a wall of the        sleeve and into the cardiac tissue;    -   withdrawing the anchor driver from the sheath and a body of the        subject, while leaving the sheath lumen of the sleeve;    -   subsequently loading a second one of the anchors onto the anchor        driver while the anchor driver is outside the body;    -   subsequently reintroducing the anchor driver into the body and        the sheath; and    -   subsequently deploying the second one of the anchors through the        wall of the sleeve into the cardiac tissue.

For some applications, placing the at least a portion of the sleeveincludes placing the at least a portion of the sleeve into a rightatrium of the subject in a vicinity of a tricuspid valve. Alternatively,placing the at least a portion of the sleeve includes placing the atleast a portion of the sleeve into a left atrium of the subject in avicinity of the annulus of a mitral valve.

There is yet additionally provided, in accordance with an embodiment ofthe present invention, a method including:

positioning, during a transcatheter procedure, an anchor deploymentmanipulator at least partially in an atrium of a subject;

placing, into the atrium in a vicinity of an annulus of anatrioventricular valve, at least a portion of an annuloplasty ring; and

coupling the annuloplasty ring to cardiac tissue by deploying at leastone anchor from the deployment manipulator in the atrium and into anupper region of a ventricular wall near the atrium.

Typically, the atrioventricular valve is selected from the groupconsisting of: a mitral valve and a tricuspid valve.

In an embodiment, positioning the anchor deployment manipulator includespositioning at least a distal end of the deployment manipulator within alumen of a sleeve of the annuloplasty ring, and coupling includescoupling the ring to the cardiac tissue by deploying the at least oneanchor from the distal end of the deployment manipulator in the atrium,through a wall of the sleeve, and into the upper region of theventricular wall. For some applications, deploying the anchor includesdeploying the anchor into the upper region of the ventricular wall whilethe distal end of the deployment manipulator is positioned such that acentral longitudinal axis of the deployment manipulator through thedistal end of the deployment manipulator forms an angle of between 45and degrees with the wall of the sleeve at a point at which the anchorpenetrates the wall.

For some applications, deploying the anchor includes deploying theanchor from the distal end of the deployment manipulator into the upperregion of ventricular wall such that a coupling element of the anchorenters the ventricular wall in a direction parallel to a centrallongitudinal axis of the deployment manipulator through the distal endof the deployment manipulator.

There is also provided, in accordance with an embodiment of the presentinvention, apparatus including an annuloplasty system for use on asubject, the system including:

an annuloplasty ring, which includes a sleeve having a lumen;

at least one anchor;

an anchor deployment manipulator, which is configured to be removablypositioned within the lumen of the sleeve, and which is configure todeploy the at least one anchor through a wall of the sleeve into cardiactissue of the subject; and

a pusher element which is positioned within the sleeve, and which isconfigured to, upon being pushed distally, move the distal end of thedeployment manipulator proximally within the sleeve by engaging aninterior surface of the sleeve.

In an embodiment, the deployment manipulator includes an outer tube thatis shaped so as to define an opening that is within 3 mm of a distal endof the tube; and an anchor driver that is positioned at least partiallywithin the outer tube, and which is configured to deploy the at leastone anchor, and the pusher element is positioned such that a proximalportion thereof is within the outer tube, and a distal portion thereofextends out of the tube through the opening and into the lumen of thesleeve.

In an embodiment, the deployment manipulator includes an outer tube; andan anchor driver that is positioned at least partially within the outertube, and which is configured to deploy the at least one anchor, and thepusher element is positioned outside of the outer tube.

For some applications, the pusher element is configured to, upon beingpushed distally, move the distal end of the deployment manipulatorproximally within the sleeve by engaging a distal end of the sleeve.Alternatively or additionally, the pusher element is configured to, uponbeing pushed distally, move the distal end of the deployment manipulatorproximally within the sleeve by engaging the wall of the sleeve.

Typically, the annuloplasty ring includes a partial annuloplasty ring.

In an embodiment, the annuloplasty ring includes a spool coupled to thesleeve, and a flexible contracting member that is coupled to the spooland the sleeve, such that winding the contracting member around thespool tightens the ring.

There is further provided, in accordance with an embodiment of thepresent invention, a method including: positioning an anchor deploymentmanipulator and a pusher element at least partially within a lumen of asleeve of an annuloplasty ring;

placing, into an atrium of a subject in a vicinity of an annulus of anatrioventricular valve, at least a portion of the sleeve that contains adistal end of the deployment manipulator and a distal end of the pusherelement;

moving the distal end of the deployment manipulator proximally withinthe sleeve by pushing the pusher element distally such that the pusherelement engages an interior surface of the sleeve; and

after moving the distal end of the deployment manipulator, deploying ananchor from the distal end of the deployment manipulator through a wallof the sleeve into cardiac tissue.

For some applications, the deployment manipulator includes an outer tubethat is shaped so as to define an opening that is within 3 mm of adistal end of the tube, and positioning the pusher element at leastpartially within the lumen of the sleeve includes positioning the pusherelement such that (a) a distal portion of the pusher element extends outof the tube through the opening and into the lumen of the sleeve, and(b) a proximal portion of the pusher element passes through the tubefrom the opening to a proximal end of the tube.

For some applications, the deployment manipulator includes an outertube, and positioning the pusher element at least partially within thelumen of the sleeve includes positioning the pusher element outside ofthe outer tube.

For some applications, moving includes moving the distal end of thedeployment manipulator by pushing the pusher element distally such thatthe pusher element engages a distal end of the sleeve. Alternatively oradditionally, moving includes moving the distal end of the deploymentmanipulator by pushing the pusher element distally such that the pusherelement engages the wall of the sleeve.

For some applications, moving the distal end of the deploymentmanipulator includes moving the distal end of the deployment manipulatora certain distance by pushing the pusher element the certain distance.

There is still further provided, in accordance with an embodiment of thepresent invention, apparatus including an annuloplasty ring for use on asubject, which includes:

a sleeve shaped so as to define a lumen therein that is open at aproximal end of the sleeve;

a contracting mechanism, coupled to the sleeve in a vicinity of a distalend of the sleeve; and

an elongated contracting member, a first end of which is coupled to thecontracting mechanism, and a second end of which is coupled to thesleeve in a vicinity of the proximal end of the sleeve,

wherein the contracting mechanism includes a driving interface that ispositioned so as to be accessible from within the lumen of the sleeve,and

wherein the contracting mechanism is configured such that rotation ofthe driving interface shortens the ring by tightening the elongatedcontracting member.

Typically, the annuloplasty ring includes a partial annuloplasty ring.

For some applications, the apparatus further includes a screwdrivertool, which includes a head and a shaft, and the screwdriver tool isconfigured to be removably inserted partially into the lumen of thesleeve via the proximal end of the sleeve, such that the head isremovably coupled from within the lumen to the driving interface of thecontracting mechanism.

In an embodiment, the apparatus further includes at least one anchor;and an anchor deployment manipulator, configured to be removablypositioned within the lumen of the sleeve, and, while so positioned, todeploy the anchor from a distal end of the deployment manipulatorthrough a wall of the sleeve into cardiac tissue of the subject.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method including:

coupling a sleeve of an annuloplasty ring to cardiac tissue of a subjectat a plurality of sites in a vicinity of an annulus of anatrioventricular valve;

partially inserting a screwdriver tool into a lumen of the sleeve, thetool having a head and a shaft; and

rotating the screwdriver tool such that the head, while within the lumenof the sleeve, shortens the ring by rotating a contracting mechanism ofthe ring that tightens an elongated contracting member coupled to thesleeve.

Typically, the annuloplasty ring includes a partial annuloplasty ring,and coupling includes coupling the sleeve of the partial annuloplastyring to the cardiac tissue.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are schematic illustrations of an adjustable partialannuloplasty ring in a non-contracted state, in accordance withrespective embodiments of the present invention;

FIG. 2 is a schematic longitudinal cross-sectional illustration of ananchor deployment manipulator, in accordance with an embodiment of thepresent invention;

FIG. 3 is a schematic longitudinal cross-sectional illustration of theanchor deployment manipulator of FIG. 2 advanced into the annuloplastyring of FIG. 1A, in accordance with an embodiment of the presentinvention;

FIG. 4 is a schematic cross-sectional illustration of the anchordeployment manipulator of FIG. 2 advanced into the annuloplasty ring ofFIG. 1A or 1B, taken along section IV-IV of FIG. 3, in accordance withan embodiment of the present invention;

FIGS. 5A-B are schematic illustrations of a screwdriver tool being usedto rotate a spool of a contracting mechanism of the rings of FIGS. 1Aand 1B, respective, in accordance with respective embodiments of thepresent invention;

FIGS. 6A-I are schematic illustrations of a procedure for implanting theannuloplasty ring of FIG. 1A to repair a mitral valve, in accordancewith an embodiment of the present invention;

FIG. 7 is a schematic illustration of the deployment of an anchor intocardiac tissue, in accordance with an embodiment of the presentinvention;

FIG. 8 is a schematic illustration of the system of FIGS. 1-4 comprisinga flexible pusher element, in accordance with an embodiment of thepresent invention;

FIG. 9 is a schematic illustration of a pusher tube applied to aproximal end of the sleeve of FIGS. 1-4, in accordance with anembodiment of the present invention;

FIGS. 10 and 11 are schematic illustrations of the system of FIGS. 1-4comprising a steerable tube, in accordance with respective embodimentsof the present invention; and

FIG. 12 is a schematic illustration of the system of FIGS. 1-4comprising a pulling wire, in accordance with an embodiment of thepresent invention.

DETAILED DESCRIPTION OF EMBODIMENTS

FIGS. 1-4 are schematic illustrations of a system for repairing adilated atrioventricular valve, such as a mitral valve, in accordancewith an embodiment of the present invention. System 20 comprises anadjustable partial annuloplasty ring 22, shown alone in FIGS. 1A and 1Bin a non-contracted state, and an anchor deployment manipulator 24,shown alone in FIG. 2. Annuloplasty ring 22 comprises a flexible sleeve26. Anchor deployment manipulator 24 is advanced into sleeve 26, asshown in FIGS. 3 and 4, and, from within the sleeve, deploys anchors 38through a wall of the sleeve into cardiac tissue, thereby anchoring thering around a portion of the valve annulus.

FIGS. 1A and 1B are schematic illustration of annuloplasty ring 22 in anon-contracted state, in accordance with respective embodiments of thepresent invention. Sleeve 26 is typically configured to be placed onlypartially around the valve annulus (i.e., to assume a C-shape), and,once anchored in place, to be contracted so as to circumferentiallytighten the valve annulus. Alternatively, the ring is configured to beplaced entirely around the valve annulus. In order to tighten theannulus, annuloplasty ring 22 comprises a flexible elongated contractingmember 30 that extends along the ring.

Annuloplasty ring 22 further comprises a contracting mechanism 40, whichfacilitates contracting of the annuloplasty ring. Contracting mechanism40 is described in more detail hereinbelow. In addition, the ringcomprises a plurality of anchors 38, typically between about 5 and about20 anchors, such as about 10 or about anchors. In FIGS. 1A and 1B,anchors 38 are shown prior to their insertion into ring 22, while inFIG. 3 one of the anchors is shown deployed through the wall of sleeve26, and a second one of the anchors is shown during deployment by anchordeployment manipulator 24. The insertion of the anchors into the sleeveand deployment of the anchors into cardiac tissue is described in detailhereinbelow.

Flexible sleeve 26 may comprise a braided, knitted, or woven mesh or atubular structure comprising ePTFE. For some applications, the braidcomprises metal and fabric fibers. The metal fibers, which may compriseNitinol for example, may help define the shape of the sleeve, e.g., holdthe sleeve open to provide space for passage and manipulation ofdeployment manipulator 24 within the sleeve. The fabric fibers maypromote tissue growth into the braid. Optionally, the sleeve is somewhatelastic, which gives the sleeve a tendency to longitudinally contract,thereby helping tighten the sleeve. For example, the sleeve may bebellows- or accordion-shaped.

Typically, the sleeve is configured to have a tendency to assume astraight shape. This straightness helps the surgeon locate the next sitefor each subsequent anchor during the implantation procedure, asdescribed hereinbelow with reference to FIGS. 6A-I. For example, becausethe sleeve assumes a generally straight shape, the sleeve may helpprovide an indication of distance between adjacent anchoring sites.

For some applications, the sleeve is configured to have a controllablyvariable stiffness. For example, a somewhat stiff wire may be placed inthe sleeve to provide the stiffness, and subsequently be removed at theconclusion of the implantation procedure when the stiffness is no longeruseful.

Elongated contracting member 30 comprises a wire, a ribbon, a rope, or aband, which typically comprises a flexible and/or superelastic material,e.g., nitinol, polyester, stainless steel, or cobalt chrome. In someembodiments, contracting member 30 comprises a braided polyester suture(e.g., Ticron). In some embodiments, contracting member 30 is coatedwith polytetrafluoroethylene (PTFE). In some embodiments, contractingmember 30 comprises a plurality of wires that are intertwined to form arope structure.

For some applications, contracting member 30 is positioned at leastpartially within a lumen of the sleeve 26, such as entirely within thelumen (as shown in FIGS. 1A-B, 5A-B, 6H, and 61). For some applicationsin which the contracting member is positioned partially within thelumen, the contracting member is sewn into the wall of the sleeve, suchthat the contracting member is alternatingly inside and outside of thesleeve along the length of the sleeve (as shown in FIGS. 3, 8, and 9).Optionally, sleeve 26 defines an internal channel within which member 30is positioned (configuration not shown). Alternatively, the contractingmember is disposed outside the lumen of the sleeve, such as alongside anouter wall of the sleeve. For example, sleeve 26 may define an externalchannel within which member 30 is positioned, or the sleeve may compriseor be shaped so as to define external coupling elements, such as loopsor rings (configuration not shown). For some applications, contractingmember 30 is positioned approximately opposite the anchors.

In an embodiment of the present invention, contracting mechanism 40comprises a housing 44 which houses a spool 46, i.e., a rotatablestructure, to which a first end 47 of contracting member 30 is coupled.Spool 46 is positioned in a vicinity of (e.g., within 1 cm of) either adistal end 51 of sleeve 26, as shown in FIGS. 1A and 3, or a proximalend 49 of sleeve 26, as shown in FIG. 1B. A second end 53 of contractingmember is coupled to the sleeve in a vicinity of (e.g., within 1 cm of)the end of the sleeve opposite the end to which the spool is positioned.In the configuration shown in FIGS. 1A and 3, second end 53 ofcontracting member 30 is coupled to the sleeve in a vicinity of proximalend 49 of the sleeve, while in the configuration shown in FIG. 1B, thesecond end of the contracting member is coupled to the sleeve in avicinity of distal end 51 of the sleeve. Rotation of spool 46 winds aportion of the contracting member around the spool, thereby pulling thefar end of the ring toward the spool and shortening and tightening thering.

Alternatively, in some configurations, spool 46 is positioned at anintermediary position along the sleeve, rather than in a vicinity of oneof the ends. For these configurations, contracting member 30 comprisestwo contracting members, which are respectively connected to the twoends of the sleeve, and both of which are connected to the spool.Rotating the spool contracts both contracting members. Theseconfiguration may be implemented using techniques described in U.S.patent application Ser. No. 12/341,960 to Cabiri, which issued as U.S.Pat. No. 8,241,351 and is incorporated herein by reference, withreference to FIG. 15 thereof.

Spool 46 is shaped to provide a hole 42 or other coupling mechanism forcoupling first end 47 of contracting member 30 to the spool, and therebyto contracting mechanism 40. Spool 46 is shaped to define a drivinginterface 48. For some applications, driving interface 48 is female. Forexample, the interface may be shaped to define a channel which extendsthrough the cylindrical portion of spool 46 from an opening provided byan upper surface 50 of spool 46 to an opening provided by a lowersurface 52 of spool 46. Alternatively, driving interface 48 is shaped soas to define an indentation (e.g., a groove) that does not extendentirely through the cylindrical portion of the spool. Furtheralternatively, driving interface 48 is male, and defines a protrusion,e.g., a hexagonal head or a head having another shape.

A distal portion of a screwdriver tool 80, which is describedhereinbelow with reference to FIGS. 5A-B, engages spool 46 via drivinginterface 48 and rotates spool 46 in response to a rotational forceapplied to the screwdriver. The rotational force applied to thescrewdriver tool rotates spool 46 via the portion of the screwdrivertool that engages driving interface 48 of spool 46.

Spool 46 typically comprises a locking mechanism that prevents rotationof the spool after contracting member 30 has been tightened. Forexample, locking techniques may be used that are described withreference to FIG. 4 of above-mentioned U.S. application Ser. No.12/341,960 to Cabiri.

Alternatively, in an embodiment of the present invention, contractingmechanism 40 is configured to tighten contracting member 30, crimp thecontracting member to hold the contracting member taut, and subsequentlycut the excess length of the contracting member.

FIG. 2 is a schematic longitudinal cross-sectional illustration ofanchor deployment manipulator 24, FIG. 3 is a schematic longitudinalcross-sectional illustration of the anchor deployment manipulatoradvanced into annuloplasty ring 22, and FIG. 4 is a schematiccross-sectional illustration of the anchor deployment manipulatoradvanced into the annuloplasty ring, taken along section IV-IV of FIG.3, in accordance with an embodiment of the present invention. Anchordeployment manipulator 24 is advanced into a lumen of sleeve 26, and,from within the lumen, deploys anchors 38 through a wall of the sleeveand into cardiac tissue, thereby anchoring the sleeve around a portionof the valve annulus. Typically, annuloplasty ring 22 and anchordeployment manipulator 24 are introduced into the heart via a sheath104, as described hereinbelow with reference to FIGS. 6A-I.

In an embodiment of the present invention, at least one of anchors 38 isdeployed from a distal end 60 of manipulator 24 while the distal end ispositioned such that a central longitudinal axis 62 through distal end60 of manipulator 24 forms an angle α (alpha) of between about 45 and 90degrees with the wall of sleeve 26 at the point at which the anchorpenetrates the wall, such as between about 75 and 90 degrees, e.g.,about 90 degrees. (In FIG. 3, a line 64 schematically illustrates theplane tangential to the wall of the sleeve at the anchor-penetrationpoint.) This anchor-penetration point is typically at a portion of thesleeve that extends distally beyond the distal end of outer tube 66 ofdeployment manipulator 24 (which is described hereinbelow), i.e., thatis no longer in contact with the outer surface of outer tube 66.Typically, all of the anchors are deployed at such angles, with thepossible exception of the first anchor deployed near the distal end ofthe sleeve.

For some applications, at least one of anchors 38 is deployed fromdistal end 60 of manipulator 24 while distal end 60 is positioned suchthat longitudinal axis 62 through distal end 60 of manipulator 24 formsan angle β (beta) of between about 45 and 90 degrees (such as betweenabout 75 and 90 degrees, e.g., about 90 degrees) with a line 65 definedby (a) a first point 67 at which the anchor currently being deployedpenetrates the wall of the sleeve and (b) a second point 69 at which amost recently previously deployed anchor penetrates the wall of sleeve26. Typically, all of the anchors are deployed at such angles, with theexception of the first anchor deployed near the distal end of thesleeve.

Typically, the anchors are deployed from distal end 60 of manipulator 24into the cardiac tissue in a direction parallel to central longitudinalaxis 62.

In an embodiment of the present invention, anchor deployment manipulator24 comprises an outer tube 66 and an anchor driver 68 which is at leastpartially positioned within tube 66. Anchor driver 68 comprises anelongated, flexible shaft 70, having at its distal end a driver head 72.Rotation of the anchor driver screws the anchors into the cardiactissue. Each of anchors 38 is shaped so as to define a coupling head 74and a tissue coupling element 76. The anchors are typically rigid.Tissue coupling elements 76 may, for example, be helical or spiral inshape (e.g., having the shape of a corkscrew), as shown in the figures,may comprises screws, or may have other shapes. Coupling heads 74 may beeither male (e.g., a hex or square protrusion) or female (e.g., astraight slot, a hex opening, a Phillips opening, or a Robertsonopening). The use of helical anchors, which are screwed into the cardiactissue, generally minimizes the force that needs to be applied duringdeployment of the anchors into the cardiac tissue. Alternatively, theanchors may comprise staples, clips, spring-loaded anchors, or othertissue anchors described in the references incorporated hereinabove inthe Background section, or otherwise known in the art. For someapplications, outer tube 66 of deployment manipulator 24 is steerable,as known in the catheter art, while for other applications, a separatesteerable tube is provided, as described hereinbelow with reference toFIG. 10 or FIG. 11. To provide steering functionality to deploymentmanipulator, outer tube 66, steerable tube 300 (FIG. 10), or steerabletube 320 (FIG. 11), as the case may be, typically comprises one or moresteering wires, the pulling and releasing of which cause deflection ofthe distal tip of the tube.

In an embodiment of the present invention, each of tissue couplingelements 76 is shaped so as to define a longitudinal axis 78 (shown inFIGS. 1A-B), and is configured to penetrate the cardiac tissue in adirection parallel to longitudinal axis 78. Deployment manipulator isconfigured to deploy tissue coupling element 76 from distal end 60 ofthe manipulator through the wall of sleeve 26 in a direction parallel tolongitudinal axis 78 and parallel to central longitudinal axis 62through distal end 60 of deployment manipulator 24 (shown in FIGS. 2, 3,and 7-10).

For some applications, the plurality of anchors are applied using themanipulator by loading a first one of the anchors onto the anchordriver, and deploying the anchor into the cardiac tissue. The anchordriver is withdrawn from the subject's body (typically while leavingouter tube 66 of the deployment manipulator in place in the sleeve), anda second one of the anchors is loaded onto the anchor driver. The anchordriver is reintroduced into the outer tube of the manipulator, and thesecond anchor is deployed. These steps are repeated until all of theanchors have been deployed. Alternatively, the entire deploymentmanipulator, including the anchor driver, is removed from the body andsubsequently reintroduced after being provided with another anchor.Further alternatively, the deployment manipulator is configured tosimultaneously hold a plurality of anchors, and to deploy them one at atime (configuration not shown).

Typically, the first anchor 38 is deployed most distally in sleeve 26(generally at or within a few millimeters of a distal end 51 of thesleeve), and each subsequent anchor is deployed more proximally, suchthat manipulator 24 is gradually withdrawn in a proximal directionduring the anchoring procedure.

Reference is now made to FIGS. 5A-B, which are schematic illustrationsof screwdriver tool 80 being used to rotate spool 46 of contractingmechanism 40 of ring 22, in accordance with respective embodiments ofthe present invention. Screwdriver tool 80 has a head 82 that is eithermale (e.g., comprising a screwdriver head, having, such as a slot-head,an Allen-head, a Phillips-head, a Robertson-head, or a hex-head) orfemale (e.g., comprising a wrench head, having, for example, a square orhex opening), as appropriate for the driving interface provided.Typically, the screwdriver tool comprises a shaft 84, at least a portionof which is flexible. For some applications, the screwdriver tool isused that is described in above-referenced U.S. patent application Ser.No. 12/341,960, with reference to FIG. 4 thereof. Alternatively, anchordriver 68 of deployment manipulator 24 serves as screwdriver tool 80,and is used to rotate the spool, in which case driving interface 48 isappropriately shaped to receive driver head 72 of anchor driver 68.

In the configuration shown in FIG. 5A, contracting member 30 is coupledto distal end 51 of sleeve 26, as shown hereinabove in FIGS. 1A and 3.Contracting mechanism 40 is oriented such that driving interface 48thereof is accessible from within sleeve 26. Screwdriver tool 80 isinserted into sleeve 26, and used to rotate spool 46 via the drivinginterface. Alternatively, anchor driver 68 of deployment manipulator 24serves as screwdriver tool 80, and is used to rotate the spool, in whichcase driving interface 48 is appropriately shaped to engage driver head72 of anchor driver 68. In either case, the sleeve thus serves to guidethe screwdriver tool to driving interface 48. For some applications, aninterior surface of the sleeve is tapered near the distal end of thesleeve, to help guide the screwdriver head to the driving interface. Forsome applications, during the implantation procedure, anchor deploymentmanipulator 24 is left slightly inserted into proximal end 49 of sleeve26 after all of anchors 38 have been deployed, in order to facilitatepassage of screwdriver tool 80 into sleeve 26.

In the configuration shown in FIG. 5B, access to driving interface 48 isprovided from outside sleeve 26. For some applications, contractingmechanism 40 comprises a wire 86 that is attached to the mechanism andpasses out of the body of the subject, typically via sheath 104. Inorder to readily bring the screwdriver tool to driving interface 48,screwdriver tool 80 is guided over (as shown) the wire, or alongside thewire (configuration not shown).

For some applications, contracting mechanism 40 is positioned in avicinity of (e.g., within 1 cm of) distal end 51 of sleeve 26, andaccess to driving interface 48 is provided from outside sleeve 26, asdescribed with reference to FIG. 5B (in which the contracting mechanismis positioned in a vicinity of proximal end 49 of the sleeve).

For some applications in which access to driving interface 48 isprovided from outside sleeve 26, the screwdriver tool is initiallyremovably attached to the driving interface, prior to the commencementof the implantation procedure, and is subsequently decoupled from thedriving interface after spool 46 has been rotated. In theseapplications, contracting mechanism 40 may be positioned in a vicinityof distal end 51 or proximal end 49 of sleeve 26, or at an intermediatelocation along the sleeve. Optionally, at least a portion of a shaft ofthe screwdriver tool is positioned within sheath 104, which is describedhereinbelow with reference to FIGS. 6A-I.

Reference is now made to FIGS. 6A-I, which are schematic illustrationsof a procedure for implanting annuloplasty ring 22 to repair a mitralvalve 130, in accordance with an embodiment of the present invention.The procedure is typically performed with the aid of imaging, such asfluoroscopy, transesophageal echo, and/or echocardiography.

The procedure typically begins by advancing a semi-rigid guidewire 102into a right atrium 120 of the patient, as shown in FIG. 6A.

As show in FIG. 6B, guidewire 102 provides a guide for the subsequentadvancement of a sheath 104 therealong and into the right atrium. Oncesheath 104 has entered the right atrium, guidewire 102 is retracted fromthe patient's body. Sheath 104 typically comprises a 14-20 F sheath,although the size may be selected as appropriate for a given patient.Sheath 104 is advanced through vasculature into the right atrium using asuitable point of origin typically determined for a given patient. Forexample:

-   -   sheath 104 may be introduced into the femoral vein of the        patient, through an inferior vena cava 122, into right atrium        120, and into a left atrium 124 transseptally, typically through        the fossa ovalis;    -   sheath 104 may be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into right atrium        120, and into left atrium 124 transseptally, typically through        the fossa ovalis; or    -   sheath 104 may be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into        right atrium 120, and into left atrium 124 transseptally,        typically through the fossa ovalis.

In an embodiment of the present invention, sheath 104 is advancedthrough an inferior vena cava 122 of the patient (as shown) and intoright atrium 120 using a suitable point of origin typically determinedfor a given patient.

Sheath 104 is advanced distally until the sheath reaches the interatrialseptum.

As shown in FIG. 6D, a resilient needle 106 and a dilator (not shown)are advanced through sheath 104 and into the heart. In order to advancesheath 104 transseptally into left atrium 124, the dilator is advancedto the septum, and needle 106 is pushed from within the dilator and isallowed to puncture the septum to create an opening that facilitatespassage of the dilator and subsequently sheath 104 therethrough and intoleft atrium 124. The dilator is passed through the hole in the septumcreated by the needle. Typically, the dilator is shaped to define ahollow shaft for passage along needle 106, and the hollow shaft isshaped to define a tapered distal end. This tapered distal end is firstadvanced through the hole created by needle 106. The hole is enlargedwhen the gradually increasing diameter of the distal end of the dilatoris pushed through the hole in the septum.

The advancement of sheath 104 through the septum and into the leftatrium is followed by the extraction of the dilator and needle 106 fromwithin sheath 104, as shown in FIG. 6E.

As shown in FIG. 6F, annuloplasty ring 22 (with anchor deploymentmanipulator 24 therein) is advanced through sheath 104 into left atrium124.

As shown in FIG. 6G, distal end 51 of sleeve 26 is positioned in avicinity of a left fibrous trigone 142 of an annulus 140 of mitral valve130. (It is noted that for clarity of illustration, distal end 51 ofsleeve 26 is shown schematically in the cross-sectional view of theheart, although left trigone 142 is in reality not located in the showncross-sectional plane, but rather out of the page closer to the viewer.)Alternatively, the tip is positioned in a vicinity of a right fibroustrigone 144 of the mitral valve (configuration not shown). Furtheralternatively, the distal tip of the sleeve is not positioned in thevicinity of either of the trigones, but is instead positioned elsewherein a vicinity of the mitral valve, such as in a vicinity of the anterioror posterior commissure. For some applications, outer tube 66 of anchordeployment manipulator 24 is steerable, as is known in the catheter art,while for other applications, a separate steerable tube is provided, asdescribed hereinbelow with reference to FIG. 10 and FIG. 11. In eithercase, the steering functionality typically allows the area near thedistal end of the manipulator to be positioned with six degrees offreedom. Once positioned at the desired site near the selected trigone,manipulator 24 deploys a first anchor 38 through the wall of sleeve 26into cardiac tissue near the trigone.

As shown in FIG. 6H, deployment manipulator 24 is repositioned alongannulus 140 to another site selected for deployment of a second anchor38. Typically, the first anchor is deployed most distally in the sleeve(generally at or within a few millimeters of the distal tip of thesleeve), and each subsequent anchor is deployed more proximally, suchthat the manipulator is gradually withdrawn in a proximal directionduring the anchoring procedure. The already-deployed first anchor 38holds the anchored end of sleeve 26 in place, so that the sleeve isdrawn from the site of the first anchor towards the site of the secondanchor. Deployment manipulator 24 deploys the second anchor through thewall of the sleeve into cardiac tissue at the second site. Depending onthe tension applied between the first and second anchor sites, theportion of sleeve 26 therebetween may remain tubular in shape, or maybecome flattened, which may help reduce any interference of the ringwith blood flow.

For some applications, in order to provide the second and subsequentanchors, anchor driver 68 is withdrawn from the subject's body viasheath 104 (typically while leaving outer tube 66 of the deploymentmanipulator in place in the sleeve), provided with an additional anchor,and then reintroduced into the subject's body and into the outer tube.Alternatively, the entire deployment manipulator, including the anchordriver, is removed from the body and subsequently reintroduced uponbeing provided with another anchor. Further alternatively, deploymentmanipulator 24 is configured to simultaneously hold a plurality ofanchors, and to deploy them one at a time at the selected sites.

As shown in FIG. 6I, the deployment manipulator is repositioned alongthe annulus to additional sites, at which respective anchors aredeployed, until the last anchor is deployed in a vicinity of rightfibrous trigone 144 (or left fibrous trigone 142 if the anchoring beganat the right trigone). Alternatively, the last anchor is not deployed inthe vicinity of a trigone, but is instead deployed elsewhere in avicinity of the mitral valve, such as in a vicinity of the anterior orposterior commissure.

As described hereinabove with reference to FIGS. 1A and 1B, ascrewdriver tool or anchor driver 68 of deployment manipulator 24 isused to rotate spool 46 of contracting mechanism 40, in order to tightenring 22. (For clarity of illustration, contracting member 30 of ring 22,although provided, is not shown in FIGS. 6A-I.) Alternatively, anothertechnique is used to tighten the ring, such as described hereinabove.

For some applications, sleeve 26 is filled with a material (e.g.,polyester, polytetrafluoroethylene (PTFE), polyethylene terephthalate(PET), or expanded polytetrafluoroethylene (ePTFE)) after beingimplanted. The material is packed within at least a portion, e.g., 50%,75%, or 100%, of the lumen of sleeve 26. The filler material functionsto prevent (1) formation within the lumen of sleeve 26 of clots or (2)introduction of foreign material into the lumen which could obstruct thesliding movement of contracting member 30.

For some applications, proximal end 49 of sleeve 26 is closed uponcompletion of the implantation procedure. Alternatively, the proximalend of the sleeve may have a natural tendency to close when not heldopen by manipulator 24.

Reference is made to FIG. 7, which is a schematic illustration of thedeployment of one of anchors 38 into cardiac tissue, in accordance withan embodiment of the present invention. In this embodiment, one or more(such as all) of anchors 38 are deployed from left atrium 124, throughtissue of the atrial wall, and into tissue of an upper region of theventricular wall 150 near the atrium. Because the tissue of the upperregion of ventricular wall is thicker than that of the atrial wall,deploying the anchors into the upper region of the ventricular wallgenerally provides more secure anchoring. In addition, because theanchors are not deployed laterally through the atrial wall, the risk ofperforating the atrial wall is reduced.

Annuloplasty ring 22 may be advanced toward annulus 140 in any suitableprocedure, e.g., a transcatheter procedure, a minimally invasiveprocedure, or an open heart procedure (in which case one or moreelements of system 20 are typically rigid). Regardless of the approach,the procedure typically includes the techniques described hereinabovewith reference to FIGS. 6G-I and 7.

For some applications, following initial contraction of annuloplastyring 22 during the implantation procedure, the ring may be furthercontracted or relaxed at a later time after the initial implantation.Using real-time monitoring, tactile feedback and optionally incombination with fluoroscopic imaging, a screwdriver tool or anchordriver 68 of deployment manipulator 24 is reintroduced into the heartand used to contract or relax annuloplasty ring 22.

Reference is now made to FIG. 8, which is a schematic illustration ofsystem 10 comprising a flexible pusher element 200, in accordance withan embodiment of the present invention. Pusher element 200 aids withaccurately positioning successive anchors 38 during an implantationprocedure, such as described hereinabove with reference to FIGS. 6H and6I. For some applications, pusher element 200 is positioned partiallywithin tube 66 of deployment manipulator 24 such that a distal portion204 of pusher element 200 extends distally out of tube 66, through anopening 206 in a vicinity of a distal end of the tube (e.g., that iswithin 3 mm of the distal end, such as within 2 mm of the distal end). Aproximal portion 202 of pusher element 200 passes through outer tube 66from opening 206 to the proximal end of tube 66. Opening 206 is providedeither through a wall of the tube (as shown in FIG. 8), or through thedistal end of the tube (configuration not shown). Alternatively, pusherelement 200 is positioned within sleeve 26, but outside of tube 66(configuration not shown). Typically, the pusher element is elongated,and is as least as long as sleeve 26.

Pusher element 200 helps move the distal end of deployment manipulator24 from a first site of the annulus at which the manipulator has alreadydeployed a first anchor (e.g., anchor 38A in FIG. 8) to a second sitefor deployment of a second anchor (e.g., anchor 38B), in a directionindicated schematically by an arrow 210. Pusher element 200 is pusheddistally out of opening 206 of tube 66, so that a distal end 212 ofpusher element 200 engages and pushes against an interior surface ofsleeve 26, in a direction indicated schematically by an arrow 214. Theinterior surface of the sleeve may be distal end 51 of the sleeve (asshown), or the wall of the sleeve at a location between distal end 51and opening 206 (not shown). As a result, the distal end of manipulator24 moves in the opposite direction, i.e., as indicated by arrow 210,toward a subsequent anchoring site. The movement in the direction ofarrow 210 is generally along a line or curve defined by the portion ofpusher element 200 already extended between the anchors that havealready been deployed.

For some applications, as manipulator 24 is positioned at successivedeployment sites of the cardiac tissue, pusher element 200 is extendedrespective distances through opening 206, each of which distances issuccessively greater. For other applications, after manipulator 24 ispositioned at each successive deployment site, the pusher element ispulled back in a proximal direction, and again extended a desireddistance in a distal direction, such that the pusher element pushesagain the wall of the sleeve (at a different location on the wall foreach successive relocation of manipulator 24).

This technique thus aids in locating each subsequent anchoring site formanipulator 24. The pusher element may also help control the distancebetween adjacent anchoring sites, because they surgeon may push thepusher element a known distance after deploying each anchor.

Pusher element 200 typically comprises a strip, wire, ribbon, or band,and has a cross-section that is circular, elliptical, or rectangular.Pusher element 200 typically comprises a flexible and/or superelasticmaterial, such as a metal such as nitinol, stainless steel, or cobaltchrome. Distal end 212 of pusher element 200 is dull, so that it doesnot penetrate sleeve 26. For example, the distal end may be folded back,as shown in FIG. 8.

FIG. 9 is a schematic illustration of a pusher tube 250 applied toproximal end 49 of sleeve 26, in accordance with an embodiment of thepresent invention. Pusher tube 250 pushes gently in a distal directionon proximal end 49 of sleeve 26. For example, if, during withdrawal ofouter tube 66 in a proximal direction, the outer tube snags on the wallof sleeve 26 (which, as mentioned above, may comprise braided or wovenfabric), such pushing may help free the snag. For some applications, thetechniques of this embodiment are practiced in combination with those ofthe embodiment described hereinbelow with reference to FIG. 12.(Although in the embodiment described with reference to FIG. 9, system10 typically comprises contracting member 30, for clarity ofillustration the contracting member is not shown in the figure.)

FIG. 10 is a schematic illustration of system 10 comprising a steerabletube 300, in accordance with an embodiment of the present invention. Inthis embodiment, outer tube 66 of deployment manipulator 24 is notsteerable. Instead, to provide steering functionality, deploymentmanipulator 24 comprises a separate steering tube 300, which ispositioned around at least a portion of outer tube 66. Outer tube 66,because it does not provide this steering functionality, may have asmaller diameter than in the embodiment described hereinabove withreference to FIG. 3. Because outer tube 66 has a smaller diameter,sleeve 26 may also have a smaller diameter than in the embodimentdescribed hereinabove with reference to FIG. 3. For some applications,the techniques of this embodiment are practiced in combination withthose of the embodiment described hereinabove with reference to FIG. 9.(Although in the embodiment described with reference to FIG. 10, system10 typically comprises contracting member 30, for clarity ofillustration the contracting member is not shown in the figure.)

FIG. 11 is a schematic illustration of system 10 comprising a steerabletube 320, in accordance with an embodiment of the present invention. Inthis embodiment, outer tube 66 of deployment manipulator 24 is notsteerable. Steering functionality is instead provided by separatesteering tube 320, which is positioned around at least a portion ofshaft 70 of anchor driver 68, and within outer tube 66. For someapplications, the techniques of this embodiment are practiced incombination with those of the embodiment described hereinabove withreference to FIG. 9. (Although in the embodiment described withreference to FIG. 11, system 10 typically comprises contracting member30, for clarity of illustration the contracting member is not shown inthe figure.)

FIG. 12 is a schematic illustration of system comprising a pulling wire340, in accordance with an embodiment of the present invention. A distalportion 342 of pulling wire 340 is coupled to proximal end 49 of sleeve26, such as by passing through one or more holes near the proximal end.One or more proximal portions 344 of the pulling wire are coupled to anexternal control handle 346 of system 10, which is manipulated by thesurgeon outside of the subject's body. Optionally, a portion ofdeployment manipulator 24 (e.g., a portion of outer tube 66) which isnever inserted in sleeve 26 comprises one or more coupling elements 348,such as loops or tubes, through which pulling wire 340 passes in orderto hold the pulling wire close to the external surface of the deploymentmanipulator.

Pulling wire 340 holds sleeve 26 surrounding deployment manipulator 24.As the pulling wire is released in a distal direction as deploymentmanipulator 24 is withdrawn in a proximal direction, the release of thesleeve allows the sleeve to gradually be removed from around thedeployment manipulator. In FIG. 12, the sleeve is shown partiallyremoved from the manipulator, including the portion of the sleevethrough which one of anchors 38 has been deployed.

For some applications, control handle 346 is configured to releasepulling wire 340 incrementally, such that each time the wire is furtherreleased by a set distance. As a result, the deployment manipulator iswithdrawn from the sleeve by this set distance, andsubsequently-deployed anchors are approximately this set distance apartfrom one another. For example, the handle may comprise a control ring350 that is coupled to proximal portions 344 of the wire, and removablyengages slots 352 on the handle that are spaced apart by this setdistance. Upon completion of the implantation procedure, in order todetach the pulling wire from the sleeve, one end of the wire may be cutor released, and the wire detached from the sleeve by pulling on theother end of the wire.

(Although in the embodiment described with reference to FIG. 12, system10 typically comprises contracting member 30, for clarity ofillustration the contracting member is not shown in the figure.)

Although annuloplasty ring 22 has been described hereinabove ascomprising a partial annuloplasty ring, in some embodiments of thepresent invention, the ring instead comprises a full annuloplasty ring.

In some embodiments of the present invention, system 20 is used to treatan atrioventricular valve other than the mitral valve, i.e., thetricuspid valve. In these embodiments, annuloplasty ring 22 and othercomponents of system 20 described hereinabove as being placed in theleft atrium are instead placed in the right atrium. Althoughannuloplasty ring 22 is described hereinabove as being placed in anatrium, for some application the ring is instead placed in either theleft or right ventricle.

For some applications, techniques described herein are practiced incombination with techniques described in one or more of the referencescited in the Background section of the present patent application.

Additionally, the scope of the present invention includes embodimentsdescribed in the following applications, which are incorporated hereinby reference. In an embodiment, techniques and apparatus described inone or more of the following applications are combined with techniquesand apparatus described herein:

-   PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral    Valve treatment techniques,” filed Mar. 15, 2006;-   U.S. Provisional Patent Application 60/873,075 to Gross et al.,    entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;-   U.S. Provisional Patent Application 60/902,146 to Gross et al.,    entitled, “Mitral valve closure techniques,” filed on Feb. 16, 2007;-   U.S. Provisional Patent Application 61/001,013 to Gross et al.,    entitled, “Segmented ring placement,” filed Oct. 29, 2007;-   PCT Patent Application PCT/IL07/001,503 to Gross et al., entitled,    “Segmented ring placement,” filed on Dec. 5, 2007, which published    as PCT Publication WO/2008/068756;-   U.S. Provisional Patent Application 61/132,295 to Gross et al.,    entitled, “Annuloplasty devices and methods of delivery therefor,”    filed on Jun. 16, 2008;-   U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled,    “Adjustable partial annuloplasty ring and mechanism therefor,” filed    on Dec. 22, 2008, which issued as U.S. Pat. No. 8,241,351;-   U.S. Provisional Patent Application 61/207,908 to Miller et al.,    entitled, “Actively-engageable movement-restriction mechanism for    use with an annuloplasty structure,” filed on Feb. 17, 2009; and-   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,    entitled, “Adjustable repair chords and spool mechanism therefor,”    filed on May 4, 2009, which issued as U.S. Pat. No. 8,147,542.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1-59. (canceled)
 60. Apparatus comprising an annuloplasty system for useon a subject, which comprises: an annuloplasty ring, which comprises asleeve having a wall defining a lumen that extends longitudinally alonga length of the sleeve; an elongated contracting member, which (a)comprises an element selected from the group consisting of: a wire, aribbon, a rope, a band, and a suture, and (b) extends along at least aportion of the sleeve and is coupled at a location along the contractingmember to the sleeve, wherein the elongated contracting member isarranged to contract the annuloplasty ring by pulling on the sleeve; asteerable tube, which is configured to provide steering functionality;at least one anchor, which is shaped so as to define a tissue couplingelement; and an anchor deployment manipulator, which (a) is removablypositioned within the lumen of the sleeve, (b) is configured, whilepositioned in the lumen, to deploy the tissue coupling element throughthe wall of the sleeve into cardiac tissue of the subject, and (c)comprises (i) an outer anchor driver tube, and (ii) an anchor driver,which is at least partially positioned within the outer anchor drivertube and comprises an elongated, flexible shaft, wherein the outeranchor driver tube is at least partially positioned within the steerabletube, such that a portion of the sleeve is radially between the outeranchor driver tube and the steerable tube.
 61. The apparatus accordingto claim 60, wherein the anchor deployment manipulator is configured todeploy the tissue coupling element while the outer anchor driver tube isat least partially positioned within the steerable tube, such that theportion of the sleeve is radially between the outer anchor driver tubeand the steerable tube.
 62. The apparatus according to claim 60, whereinthe annuloplasty system further comprises a sheath, which removablysurrounds at least a portion of the sleeve, the steerable tube, and theanchor deployment manipulator.
 63. The apparatus according to claim 60,wherein the annuloplasty system further comprises a contractingmechanism, which is coupled to (a) the contracting member at a locationalong the contracting member and (b) the sleeve.
 64. The apparatusaccording to claim 63, wherein the contracting mechanism comprises ahousing.
 65. The apparatus according to claim 63, wherein thecontracting mechanism comprises a locking mechanism.
 66. The apparatusaccording to claim 63, wherein the lumen of the sleeve has an opening ata proximal end of the sleeve, wherein the steerable tube passes throughthe opening, and wherein the contracting mechanism is positioned in avicinity of a distal end of the sleeve.
 67. The apparatus according toclaim 60, wherein the steerable tube comprises one or more steeringwires, which are arranged such that pulling and releasing of thesteering wires cause deflection of a distal tip of the steerable tube,thereby providing the steering functionality.
 68. The apparatusaccording to claim 60, wherein the steering functionality is configuredto position an area near a distal end of the anchor deploymentmanipulator with six degrees of freedom.
 69. A method comprising:providing an annuloplasty system, which includes (a) an annuloplastyring, which comprises a sleeve having a wall defining a lumen thatextends longitudinally along a length of the sleeve, (b) an elongatedcontracting member, which (i) includes an element selected from thegroup consisting of: a wire, a ribbon, a rope, a band, and a suture, and(ii) extends along at least a portion of the sleeve and is coupled at alocation along the contracting member to the sleeve, (c) a steerabletube, which is configured to provide steering functionality, (d) atleast one anchor, which is shaped so as to define a tissue couplingelement, and (e) an anchor deployment manipulator, which includes (i) anouter anchor driver tube, and (ii) an anchor driver, which is at leastpartially positioned within the outer anchor driver tube and includes anelongated, flexible shaft; placing, into an atrium of a subject in avicinity of an annulus of an atrioventricular valve, the sleeve whilethe anchor deployment manipulator is removably positioned in the lumenof the sleeve; steering the anchor deployment manipulator using thesteerable tube, while the outer anchor driver tube is at least partiallypositioned within the steerable tube, such that a portion of the sleeveis radially between the outer anchor driver tube and the steerable tube;deploying the tissue coupling element from the anchor deploymentmanipulator through the wall of the sleeve into cardiac tissue of thesubject, while the anchor deployment manipulator is positioned in thelumen; and contracting the annuloplasty ring by pulling on the sleevewith the elongated contracting member.
 70. The method according to claim69, wherein deploying the tissue coupling element comprises deployingthe tissue coupling element from the anchor deployment manipulator whilethe outer anchor driver tube is at least partially positioned within thesteerable tube, such that the portion of the sleeve is radially betweenthe outer anchor driver tube and the steerable tube.
 71. The methodaccording to claim 69, wherein placing the at least a portion of thesleeve into the atrium comprises advancing the sleeve, the steerabletube, and the anchor deployment manipulator through a sheath.
 72. Themethod according to claim 69, wherein contracting the annuloplasty ringcomprises actuating a contracting mechanism of the annuloplasty systemto pull on the portion of the sleeve with the elongated contractingmember, and wherein the contracting mechanism is coupled to (a) thecontracting member at a location along the contracting member and (b)the sleeve.
 73. The method according to claim 72, wherein thecontracting mechanism includes a housing.
 74. The method according toclaim 72, wherein the contracting mechanism includes a lockingmechanism.
 75. The method according to claim 72, wherein the lumen ofthe sleeve has an opening at a proximal end of the sleeve, wherein thesteerable tube passes through the opening, and wherein the contractingmechanism is positioned in a vicinity of a distal end of the sleeve. 76.The method according to claim 69, wherein the steerable tube includesone or more steering wires, and wherein steering the anchor deploymentmanipulator comprises pulling and releasing the steering wires todeflect a distal tip of the steerable tube.
 77. The method according toclaim 69, wherein steering the anchor deployment manipulator comprisespositioning an area near a distal end of the anchor deploymentmanipulator with six degrees of freedom.